The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 17
- 主要终点
- Change in Office Systolic Blood Pressure
研究概览
简要总结
The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic, as best available antihypertensive therapy
详细描述
The HTN-J study is a multi-center, prospective, unblinded, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the MDT-2211 renal denervation system - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is ≥ 20 and ≤ 80 years old at time of randomization.
- •Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 6 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
- •Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
- •Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
排除标准
- •highlights:
- •Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- •Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg
- •Individual has type 1 diabetes mellitus
- •Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- •Individual has primary pulmonary hypertension.
- •Individual is pregnant, nursing or planning to be pregnant.
研究组 & 干预措施
Renal denervation
Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications.
干预措施: MDT-2211 Renal Denervation System (Device)
Control Group
Subjects are maintained on baseline anti-hypertensive medications
结局指标
主要结局
Change in Office Systolic Blood Pressure
时间窗: Baseline to 6 months post-randomization
次要结局
- Incidence of Major Adverse Events (MAE)(Baseline through 1 month post-randomization)